Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Platform Trial (RATIONAL-PT) Domain Addendum - Immunoglobulin Stopping or Extension (Stop-Ig)

Phase 2

• Conditions: Cancer - Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma; haematological malignancy; Cancer - Myeloma; hypogammaglobulinemia; Cancer - Leukaemia - Acute leukaemia

• Registration Number: ACTRN12624000963527
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-08
• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Patients are eligible for the Stop-Ig domain of the RATIONAL-PT if they fulfil eligibility for both RATIONAL-PT and the Stop-Ig domain.

RATIONAL-PT inclusion criteria:
1. Aged greater than or equal to 18 years of age
2. Diagnosis of haematological malignancy, including Chronic Lymphocytic Leukaemia (CLL), Multiple Myeloma (MM) or Non-Hodgkin's Lymphoma (NHL)
3. Eligible to receive or currently receiving Ig (IV or subcutaneous - SCIg) replacement for history of recurrent or severe infection(s) and IgG less than the lower limit of the reference range (excluding paraprotein) OR IgG<4g/L (excluding paraprotein)
4. Life expectancy > 12 months
5. Able to give informed consent

Stop-Ig domain inclusion criteria:
1. Patients must be receiving Ig (IV or subcutaneous - SCIg) replacement for prevention of bacterial infections due to hypogammaglobulinaemia for at least 6 consecutive months.
2. Patient is eligible for trial of Ig cessation in the opinion of the treating clinician and local investigator.
3. Willing and able to comply with each of the treatment arms.

Exclusion Criteria

Patients are eligible for the Stop-Ig domain of the RATIONAL-PT if they fulfil eligibility for both RATIONAL-PT and the Stop-Ig domain.

RATIONAL-PT exclusion criteria:
1. Treating team deems enrolment in the study is not in the best interests of the patient

Stop-Ig domain exclusion criteria:
1. Prior or planned allogeneic haematopoietic stem cell transplantation.
2. Major infection (Grade 3 or higher) in preceding 3 months, and/or current active infection requiring systemic antimicrobial treatment.
3. Already receiving systemic antibiotic prophylaxis for the purpose of preventing bacterial infection (NB: patients may receive antiviral, antifungal and Pneumocystis jirovecii Pneumonia (PJP) prophylaxis).
4. Intolerance of all trial antibiotic options in either arm A or arm B.
5. Communication, compliance or logistical issues (e.g. living long distance from medical facility) that are likely to limit a patient’s ability to take prophylactic or emergency antibiotics, or to obtain urgent medical attention for symptoms of infection.
6. Pregnant or breastfeeding.
7. Severe renal impairment (estimated or measured creatinine clearance of <30mL/min).
8. Previous splenectomy.
9. Previous participation in this domain
10. Treating team deems enrolment in the domain is not in the best interests of the patient.

Study & Design

• Study Type: Interventional
• Study Design: Not specified